Postoperative ComplicationsNCT02961075
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
A study testing local surface anesthesia and Laryngeal tube in people with Postoperative Complications, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- local surface anesthesia and Laryngeal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III
Who cannot join
- use of immunosuppressive agents or corticosteroids
- body temperature 37.3°C during the 24 h prior to FOB,intubation or mechanical ventilation
- therapeutic bronchoscopy (foreign body removal, bronchial toilet, or stenting), discharge within 24 h of FOB
- surgical or diagnostic procedures within 24 h of FOB.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116000
About this study
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
Read the detailed description
Fiberoptic bronchoscopy (FOB) is the essential procedures for diagnosis and treatment of respiratory diseases。 Fever following FOB has been frequently reported. Fever is usually caused by patient discomfort and delay recovery from illness, or even worse. The reported frequency of this complication ranges from 1 to 20%. According to previous reports, postbronchoscopy fever is associated with advanced age, the presence of abnormal bronchoscopic findings,documented endobronchial obstruction, bronchoscopic intervention for malignancy, BAL, bronchial brushing, endotoxin contamination during bronchoscopy, instillation of topical anesthetic through the bronchoscope, abnormal differential cell counts in the BAL fluid (BALF), bacterial growth in the BALF culture,and the severity of bleeding. At present, guidelines recommend sedation and analgesia combined with airway surface anesthesia for Fiberoptic bronchoscopy. laryngeal spray and cricothyroid anesthesia often used in clinical.Cricothyroid local anesthesia has a good effect, but it is an invasive operation, this is risk factors for fever after bronchoscopy.Therefore, to compare fever in the two kinds of airway anesthesia on Bronchoscopy . So as to provide the local anesthesia method with little influence on the patient.
- Conditions
- Postoperative Complications
- Being tested
- local surface anesthesia, Laryngeal tube
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local surface anesthesiaOther
Airway anesthesia for Bronchoscopy
Laryngeal tubeDevice
| Study group | Role | What they receive |
|---|---|---|
| Cricothyroid | Experimental | local surface anesthesia by Cricothyroid Receives: Other: local surface anesthesia |
| Laryngeal tube | Experimental | local surface anesthesia by Laryngeal tube Receives: Other: local surface anesthesia; Device: Laryngeal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever
Fever was defined as an axillary body temperature 37.3°C
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao z yang, MD,PhD, Study director, 0866-17709873399
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961075
- Sponsor's protocol ID
- post2016taper
- Status last verified
- Nov 2016
- First submitted
- 9 Nov 2016
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02961075
- Acronym / sponsor ID
- post2016taper
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impact of Local Anesthesia on Postbronchoscopy Fever: a Randomised Controlled Study
Detailed description
Fiberoptic bronchoscopy (FOB) is the essential procedures for diagnosis and treatment of respiratory diseases。 Fever following FOB has been frequently reported. Fever is usually caused by patient discomfort and delay recovery from illness, or even worse. The reported frequency of this complication ranges from 1 to 20%. According to previous reports, postbronchoscopy fever is associated with advanced age, the presence of abnormal bronchoscopic findings,documented endobronchial obstruction, bronchoscopic intervention for malignancy, BAL, bronchial brushing, endotoxin contamination during bronchoscopy, instillation of topical anesthetic through the bronchoscope, abnormal differential cell counts in the BAL fluid (BALF), bacterial growth in the BALF culture,and the severity of bleeding. At present, guidelines recommend sedation and analgesia combined with airway surface anesthesia for Fiberoptic bronchoscopy. laryngeal spray and cricothyroid anesthesia often used in clinical.Cricothyroid local anesthesia has a good effect, but it is an invasive operation, this is risk factors for fever after bronchoscopy.Therefore, to compare fever in the two kinds of airway anesthesia on Bronchoscopy . So as to provide the local anesthesia method with little influence on the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cricothyroid | Experimental | Other: local surface anesthesialocal surface anesthesia by Cricothyroid |
| Laryngeal tube | Experimental | Other: local surface anesthesia, Device: Laryngeal tubelocal surface anesthesia by Laryngeal tube |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-III
Key exclusion criteria (4 listed)
- use of immunosuppressive agents or corticosteroids
- body temperature 37.3°C during the 24 h prior to FOB,intubation or mechanical ventilation
- therapeutic bronchoscopy (foreign body removal, bronchial toilet, or stenting), discharge within 24 h of FOB
- surgical or diagnostic procedures within 24 h of FOB.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local surface anesthesiaAirway anesthesia for Bronchoscopy | Other | Cricothyroid, Laryngeal tube |
| Laryngeal tube | Device | Laryngeal tube |
Primary outcome
Fever
Time frame: 48 hour
Fever was defined as an axillary body temperature 37.3°C
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiao z yang, MD,PhD study director
0866-17709873399
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local surface anesthesia and Laryngeal tube in people with Postoperative Complications, run by The Second Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever (time frame: 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.